Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06862063

Next Generation Sequencing Analysis of Patients with Spontaneous Dissection of Cervical Arteries

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-03-06

145

Participants Needed

1

Research Sites

313 weeks

Total Duration

On this page

Sponsors

F

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead Sponsor

I

IRCCS National Neurological Institute "C. Mondino" Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this observational study is to analyze the existence of a genetic predisposition in patients with spontaneous dissections of the cervical arteries (SCeAD). The main questions it aims to answer are: 1. Which is the prevalence of pathogenic variants in genes coding for proteins involved in the structure or function of the connective tissue in adult patients with spontaneous dissections of the cervical arteries? 2. Which are the clinical characteristics of each single genetic variant identified? 3. Which are the clinical, radiological, laboratory variables associated with the finding of a pathogenic variant? 4. Are there differences between patients with SCeAD who have a pathogenic variant in a gene coding for proteins involved in the structure or function of the connective tissue and those who not? 5. There are differences in the risk of SCeAD recurrence between patients with SCeAD who have a pathogenic variant in a gene coding for proteins involved in the structure or function of the connective tissue and those who not? 6. There are differences in the risk of SCeAD recurrence based on the specific typology of genetic variant found? Participants will be asked to undergo: * a whole-CT total-body with contrast; * a dysmorphological visit; * a blood sampling for genetic testing; * a neurological visit; * Some follow-up visits.

CONDITIONS

Official Title

Next Generation Sequencing Analysis of Patients with Spontaneous Dissection of Cervical Arteries

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Presence of dissection in one or more cervical arteries (carotid or vertebrobasilar), confirmed by imaging showing intramural hematoma, pseudoaneurysmal dilation, intimal flap, double lumen, or long tapering stenosis or occlusion above the carotid bifurcation
  • At least one of the following: radiological evidence of vessel wall abnormalities in other vascular districts, family history of vessel dissections or early cardiovascular/cerebrovascular diseases, spontaneous organ perforation or connective tissue laxity, or clinical signs of connective tissue disease such as a Beighton score ≥5 or Marfan score ≥7
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Recent trauma clearly linked to the dissection
  • Dissection caused by an endovascular procedure
  • Dissection occurring only inside the brain vessels
  • Diagnosis of fibromuscular dysplasia

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Lazio, Italy, 00168

Actively Recruiting

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Research Team

G

Giovanni Frisullo, MD, PhD

CONTACT

I

Irene Scala, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Next Generation Sequencing Analysis of Patients with Spontaneous Dissection of Cervical Arteries | DecenTrialz